Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET

Completed

• Conditions: Cancer; Radiotherapy; Positron Emission Tomography; Radioembolization
• Interventions: Diagnostic Test: 18F-Fluoromisonidazole PET

• Registration Number: NCT06027021
• Lead Sponsor: Ankara University

Brief Summary

Hypoxia is a known factor for resistance to radiotherapy in tumors. Response to transarterial radioembolization is known to be variable between different patients even if the same dose of radiation was delivered. In this study the investigators aim to quantify the hypoxia in the primary and secondary tumors of liver with 18F-FMISO PET before radioembolization and to prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to ensure treatment response.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-07
• Primary Completion: 2024-05-15
• Status Verified: 2024-07
• Study Completion: 2024-07-15
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Diagnosed with colorectal carcinoma with liver metastasis or hepatocellular carcinoma.
• Is not eligible for surgery
• Above 18 years old
• The patients who are referred for transarterial radioembolization treatment to Ankara University School of Medicine Department of Nuclear Medicine.

Exclusion Criteria

• Patients with ECOG performance score >1
• Claustrophobia
• Life expectancy shorter than 3 months
• Pregnant or breast-feeding patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	18F-Fluoromisonidazole PET	Patients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases

Primary Outcome Measures

Name	Time	Method
Demonstrate the effect of the hypoxia in the success of the radioembolization treatment	08/2024	Demonstrate the effect of the hypoxia in the success of the radioembolization treatment
The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.	08/2024	The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.

Trial Locations

Locations (1)

Ankara University; 🇹🇷 Ankara, Turkey